Early Speech and Swallowing Therapy for Head and Neck Cancer

(ESSI-SURG Trial)

Overseen By Trixie Reichardt, MHSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Total glossectomy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how early speech and swallowing therapy can benefit individuals with head and neck cancer, particularly those with tongue cancer undergoing surgery. It will assess whether starting therapy before surgery can prevent issues like painful swallowing and weight loss, which often occur post-surgery. The trial includes two groups: one receiving standard care (Standard-of-Care) and the other receiving early speech and swallowing therapy (ESSI-SURG). Individuals newly diagnosed with tongue cancer and planning surgery may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future care for tongue cancer patients.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your doctor for guidance.

What prior data suggests that this early speech and swallowing therapy is safe for head and neck cancer patients?

Research has shown that early speech and swallowing therapy, such as ESSI-SURG, is generally safe for patients. Although specific safety data for this therapy is not available, its non-invasive nature—requiring no surgery or medication—typically reduces the risk of side effects. The therapy involves collaborating with a speech-language pathologist to learn techniques that aid swallowing. As this treatment is already part of standard care, it is considered well-tolerated. Since the trial is in an early stage, the primary goal is to assess the therapy's practicality and effectiveness, rather than focusing on safety as in drug trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ESSI-SURG intervention for head and neck cancer patients because it offers a proactive approach to speech and swallowing issues. Unlike the standard care, which typically involves referring patients to a speech-language pathologist (SLP) only after problems are suspected, ESSI-SURG provides early behavioral intervention by a live SLP. This proactive involvement may help prevent or reduce the severity of swallowing difficulties, improving patients' quality of life during treatment. By addressing potential issues early, ESSI-SURG aims to offer more effective management of speech and swallowing functions, setting it apart from the reactive approach of current treatments.

What evidence suggests that this trial's treatments could be effective for head and neck cancer?

This trial will compare early speech and swallowing therapy with standard care for head and neck cancer patients. Research has shown that starting speech and swallowing therapy early can benefit these patients. Participants in the intervention arm will work with speech-language pathologists (SLPs) before any issues develop, learning ways to improve swallowing. This early intervention can lower the risk of problems like pneumonia and malnutrition by reducing the time patients need feeding tubes. Studies have found that addressing swallowing issues early can greatly improve the quality of life for cancer survivors. Overall, early sessions with SLPs may lead to better health and fewer long-term problems for patients. ^{1 2 4 5 6}

Who Is on the Research Team?

Rosemary Martino, PhD

Principal Investigator

University Health Network, Toronto

Jonathan Irish, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for newly diagnosed patients with at least T2 stage tongue cancer, scheduled for partial tongue removal and reconstruction surgery. They should be able to eat on their own after surgery and must understand English well.

Inclusion Criteria

Proficient in spoken and written English

I am newly diagnosed with stage T2 or higher tongue cancer and will have surgery and reconstruction.

Exclusion Criteria

I am scheduled for a surgery to remove my entire tongue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgical Intervention

Participants engage with speech-language pathologists (SLPs) to learn swallow strategies before surgery

Baseline to surgery

Post-Surgical Treatment

Participants receive either standard care or the ESSI-SURG behavioural intervention by a live SLP

5 weeks

Regular visits with SLP

Follow-up

Participants are monitored for long-term changes in clinical and patient-reported outcomes

1 month after treatment

What Are the Treatments Tested in This Trial?

Interventions

• ESSI-SURG
• Standard-of-Care

Trial Overview The study tests if early intervention by speech-language pathologists (SLPs) before problems start can help head and neck cancer patients recover better post-surgery. It compares this new approach (ESSI-SURG) with the usual care given.

How Is the Trial Designed?

Group I: Arm 2 - Intervention Experimental Treatment 1 Intervention

Participants in this Arm will receive the ESSI-SURG behavioural intervention by a live SLP.

Group II: Arm 1 - Control Active Control 1 Intervention

Participants in this Arm will receive the current standard of care, which includes a referral to SLP in response to suspicion of a swallowing problem from either assessment by the medical team and/or patient report.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

In a study involving 1334 patients who underwent radical surgery for oral and oropharyngeal cancer, a significant number reported speech (63.8%) and swallowing (75.4%) impairments after treatment.

Patients with late-stage tumors (III-IV), those receiving radiotherapy, and tumors located in the floor of the mouth are at a higher risk for persistent severe speech and swallowing issues, highlighting the need for better patient education regarding these potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speech and swallowing impairment after treatment for oral and oropharyngeal cancer. Suarez-Cunqueiro, MM., Schramm, A., Schoen, R., et al.[2022]

The study evaluated a novel intervention combining Cognitive Behavioural Therapy with swallowing therapy (CB-EST) for head and neck cancer patients with dysphagia, showing promising improvements in swallowing and quality of life measures after treatment.

Out of 43 eligible patients, 70% participated, and 25 completed the intervention, with significant improvements noted in swallowing-related quality of life and dietary restrictions, indicating the potential effectiveness of this combined approach, although further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of combining cognitive behavioural therapy techniques with swallowing therapy in head and neck cancer dysphagia. Patterson, JM., Fay, M., Exley, C., et al.[2022]

In a study of 5404 participants with head and neck cancer, significant swallowing difficulties were reported four months after treatment, with scores indicating a clinically meaningful decline, but minimal changes observed by 12 months.

Factors such as cancer type, stage, treatment method, and socio-demographic variables were identified as predictors of better swallowing outcomes, highlighting the need for targeted interventions for those at higher risk of long-term swallowing issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in, and predictors of, swallowing and social eating outcomes in head and neck cancer survivors: A longitudinal analysis of head and neck 5000. Patterson, JM., Lu, L., Watson, LJ., et al.[2022]

In a 3-month pilot clinic involving 218 patients with head and neck cancer, Speech and Language Therapists (SLTs) effectively conducted assessments and treatment planning, demonstrating a safe collaboration with otolaryngologists.

The clinic identified a low cancer diagnostic yield of 5%, but found that higher scores on voice assessments (GRBAS) and patient-reported outcomes (VHI-10) were associated with a greater risk of serious diagnoses, suggesting these measures could help in identifying patients needing further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of an Advanced Speech and Language Therapist-Led Low-Risk 2-Week Wait Clinic for Suspected Head and Neck Cancer: A UK-Based Pilot Study. Butler, J., Sellstrom, D., Eastwood, N., et al.[2023]

In a study of 81 patients with early-stage oral squamous cell carcinoma, transoral resection and sentinel node biopsy resulted in excellent long-term speech and swallowing function, with scores in the highest 10% of assessment scales after a median follow-up of 60 months.

The study found that factors like tumor size, age, and additional treatments did not significantly affect speech and swallowing outcomes, indicating that the surgical approach is effective for maintaining quality of life in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term speech and swallowing function after primary resection and sentinel node biopsy for early oral squamous cell carcinoma. Romer, CAE., Broglie Daeppen, MA., Mueller, M., et al.[2020]

A study involving 89 head and neck cancer patients showed that using multiple patient-reported outcome instruments, specifically the Sydney Swallow Questionnaire (SSQ) and the MD Anderson Dysphagia Inventory (MDADI), provides valuable insights into swallowing function and dysphagia risk after treatment.

The analysis revealed a significant correlation between the SSQ and MDADI scores, and identified three distinct patient clusters, suggesting that a personalized approach to managing dysphagia in head and neck cancer treatment may be more effective than relying on a single assessment tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative Evaluation of Head and Neck Cancer Treatment-Related Dysphagia in the Development of a Personalized Treatment Deintensification Paradigm. Quon, H., Hui, X., Cheng, Z., et al.[2018]

In the LUX-Head and Neck 1 trial involving 480 patients with recurrent/metastatic head and neck squamous cell carcinoma, afatinib showed high treatment adherence (89% of patients took ≥80% of their medication) and manageable safety across various subgroups, with common side effects including diarrhea and rash.

Afatinib demonstrated similar efficacy in progression-free survival (PFS) regardless of administration method (oral or feeding tube), with a median PFS of approximately 2.6 months, indicating it is a viable treatment option for patients with difficulties swallowing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Afatinib as second-line treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck: Subgroup analyses of treatment adherence, safety and mode of afatinib administration in the LUX-Head and Neck 1 trial. Haddad, R., Guigay, J., Keilholz, U., et al.[2020]

In a study of 184 patients with advanced head and neck cancer who underwent chemoradiotherapy, 84.7% had normal speaking function and 63.3% had normal swallowing function on average 34.8 months after treatment, indicating a high rate of recovery.

Factors negatively impacting speech included being female, having a smoking history, and poor response to initial chemotherapy, while older age and poor performance status were linked to worse swallowing outcomes, highlighting the need for tailored patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with long-term speech and swallowing outcomes after chemoradiotherapy for locoregionally advanced head and neck cancer. Mouw, KW., Haraf, DJ., Stenson, KM., et al.[2010]

Patients with oropharyngeal head and neck cancer who were evaluated in a multidisciplinary clinic attended significantly more speech-language pathology (SLP) sessions (1.8 visits) compared to those evaluated outside this setting (0.2 visits), indicating that the clinic model enhances treatment compliance.

Older patients (≥ 60 years) and those evaluated in the multidisciplinary clinic were more likely to participate in SLP treatment, with the clinic model showing a strong association with compliance (odds ratio of 12.9), suggesting that structured, team-based care may improve adherence to therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary head and neck cancer clinic and adherence with speech pathology. Starmer, H., Sanguineti, G., Marur, S., et al.[2011]

Early and frequent involvement of Speech-Language Pathologists (SLPs) significantly improves speech and swallowing functions in patients with head and neck cancer, enhancing their overall quality of life.

The chapter presents various strategies and tools that can help optimize communication and ensure safe swallowing for these patients, addressing the negative impacts of cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of the Speech-Language Pathologist (SLP) in the Head and Neck Cancer Team. Hansen, K., Chenoweth, M., Thompson, H., et al.[2019]

The Italian Speech Handicap Index is a reliable and valid tool for assessing speech impairment in head and neck cancer patients, showing strong internal consistency (Cronbach α = 0.9) and test-retest reliability.

A significant difference in scores between patients and asymptomatic subjects was found, with a cut-off value of 14.5 demonstrating high sensitivity (96%) and specificity (100%), making it effective for identifying speech-related quality of life issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric properties of the Italian version of the Speech Handicap Index. Mozzanica, F., Scarponi, L., Rota, M., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06192771

Feasibility of Early Swallowing and Speech Intervention for ... This study will assess the feasibility of conducting a prospective clinical trial that would evaluate the effects on patient health, function and overall ...

2. patlynk.com patlynk.com/trial/NCT06192771

ESSI-SURG | Feasibility of Early Swallowing and Speech ... This study explores the feasibility of starting a clinical trial to evaluate the impact of early speech and swallowing interventions provided by SLPs for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9930077/

Dysphagia Advances in Head and Neck Cancer - PMC This review summarises the current literature regarding head and neck cancer–associated dysphagia. Up-to-date evidence for dysphagia outcome measurement for ...

4. trial.medpath.com trial.medpath.com/clinical-trial/edb0b50125f8d163/nct06192771-feasibility-early-swallowing-speech-intervention-head-neck-cancer-patients

Feasibility of Early Swallowing and Speech Intervention for ... This study will assess the feasibility of conducting a prospective clinical trial that would evaluate the effects on patient health, function and overall ...

5. withpower.com withpower.com/trial/phase-head-and-neck-neoplasms-11-2023-cdf77

Early Speech and Swallowing Therapy for Head and Neck Cancer Yes, ESSI-SURG, Standard-of-Care is a promising treatment for head and neck cancer. Early involvement of Speech-Language Pathologists (SLPs) can improve speech ...

6. ctv.veeva.com ctv.veeva.com/study/feasibility-of-early-swallowing-and-speech-intervention-for-head-and-neck-cancer-patients-treated-su

Feasibility of Early Swallowing and Speech Intervention for ... This study will assess the feasibility of conducting a prospective clinical trial that would evaluate the effects on patient health, function ...